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Incidence of Deep-Venous Thrombosis in Nursing Home Residents Using Megestrol Acetate
Incidence of Deep-Venous Thrombosis in Nursing Home Residents Using Megestrol Acetate Benjamin Kropsky, MD, Yong Shi, MD, and E. Paul Cherniack, MD Objective: To determine the incidence of deep venous thrombosis in users of megestrol acetate in population of institutionalized elderly. Design: Retrospective chart review. Setting: A teaching nursing home in New York City. Measurements: Number of cases of deep venous thrombosis in megesterol users.
Megestrol has been proposed as a possible treatment for anorexia in the elderly, but proof of its efficacy is limited. Yeh et al. conducted a placebo-controlled trial among institutionalized elderly subjects. A total of 69 subjects were enrolled in that study; however, only 51 completed it. Of those, 61.9% were reported to have gained at least 4 pounds after 3 months, whereas only 21.7% of the placebo group gained weight (P ⫽ 0.013).1 Deep venous thrombosis (DVT) has been found to occur in almost one-third of all megestrol users, according to one small study of nursing home residents.2 In the present study, the incidence of deep venous thrombosis was determined in a much larger population of institutionalized elderly. METHODS A retrospective chart review was performed of the 816resident Bronx division of the Jewish Home, a large teaching nursing home in New York City. All of the patients prescribed megestrol between January 1998 and October 2001 were identified by computerized pharmacy records. All cases of DVT during the same time period were selected from the clinical database. The charts of the patients who were indicated as both having a DVT and being prescribed megestrol The Jewish Home and Hospital for the Aged, Bronx, New York (B.K., Y.S., E.P.C.); Brookdale Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, New York (B.K., E.P.C.); and Miami VA GRECC, Miami VA Medical Center; and the University of Miami School of Medicine, Miami, Florida (E.P.C.). Address correspondence to: E. Paul Cherniack, MD, Miami VA GRECC, Miami VA Medical Center, University of Miami School of Medicine, 1201 NW 16 St., Miami, FL 33162. E-mail: [email protected].
Copyright ©2003 American Medical Directors Association DOI: 10.1097/01.JAM.0000083384.84558.75 ORIGINAL STUDIES
Results: The incidence of deep venous thrombosis in 246 users was 4.9% Conclusion: There is a six-fold higher incidence of deep venous thrombosis among megestrol users in this population than in the general population of institutionalized elderly. (J Am Med Dir Assoc 2003; 4: 255–256) Keywords: megestrol, elderly, deep venous thrombosis
were reviewed by an investigator to verify that patients were on megestrol at the time of occurrence of DVT and to ascertain if other risk factors for development of DVT were present, including: immobility, cancer, previous DVT estrogen treatment, or recent fracture. The authors of this study have no relationship with the manufacturers of megestrol acetate. RESULTS Table 1 shows the baseline demographic characteristics of the patients. A total of 246 nursing home residents (average age, 86.9 years) were given megestrol over the 3-year period studied. All subjects were treated with doses of 400 mg/day. Within this group, only 10 were noted to have had a DVT during the study period. Of those 10 residents, only 8 were on megestrol at the time of occurrence of their DVT, or a 4.9% incidence. Megestrol users who sustained a DVT used the agent for an average of 183 days. DISCUSSION The incidence of DVT in the community is approximately 0.1%,3 and the risk in nursing home residents is believed to be eight times that of the general population.4 Therefore, the incidence of DVT noted in this study is six-fold larger than one would expect in the absence of other factors. Although at least one previous study, Bolen et al.2 had identified DVT as a frequent common side effect of megestrol, we did not find as large incidence of DVT in our population. The Bolen study was performed on a very small number of subjects with a relatively limited follow-up time, which might Kropsky et al. 255
Table 1.
Baseline Demographic Characteristics
Male %
White %
Black %
Hispanic %
No data available %
23.1
50.4
22.4
16.3
10.9
CONCLUSION This study shows an association between the use of megestrol acetate and DVT among nursing home residents. Further research is needed to clarify the nature of this association. REFERENCES
account for differences between that study and the present investigation. An increased incidence of DVT in the use of megestrol for cachexia has been reported in Acquired Immune Deficiency Syndrome (AIDS)5 and cancer patients.6 In an examination of the hemostatic effect of megestrol in patients with gynecologic neoplasms, Oberhoff et al. did not note any effect of megestrol on parameters of coagulation such as clotting times, fibrinogen, factor VII, and thrombin-antithrombin III complex.7 Nursing home residents commonly have a number of risk factors for DVT such as immobility, frequent falls, or neoplasms, which are in and of themselves risk factors for DVT, and so it is difficult to attribute the incidence of DVT to megestrol use alone. This survey did not control for other DVT risk factors.
256 Kropsky et al.
1. Yeh SS, Wu SY, Lee TP, et. al. Improvement in quality of life measures and stimulation of geriatric cachexia: Results of a double-blind, placebocontrolled study. J Am Ger Soc 2000;43:485– 492. 2. Bolen J, Andersen RE, Bennet RG. Deep venous thrombosis as a complication of megesterol acetate therapy among nursing home residents. J Am Med Dir Assoc 2000;1:248 –252. 3. Heit JA, Silverstein MD, Mohr DN, et. al. The epidemiology of venous thromboembolism in the community. Thromb Haemost 2001;86:452– 463. 4. Heit JA, Silverstein MD, Mohr DN, et. al. Risk factors for deep venous thrombosis and pulmonary embolism: A population-based case-control study. Arch Int Med 2000;160:809 – 815. 5. Koller E, Gibert C, Green L, et. al. Thrombotic events associated with megestrol acetate in patients with AIDS cachexia. Nutrition 1999;15: 294 –298. 6. Loprinzi CL, Kugler JW, Sloan JA, et. al. Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. J Clin Oncol 1999;17:3299 – 3306. 7. Oberhoff C, Hoffman O. Winkler UH, et. al. Hemostatic effects of high-dose megestrol acetate therapy in patients with advanced gynecological cancer. Gynecol Endocrinol 2001;15:341–348.
JAMDA – September/October 2003
Megestrol has been proposed as a possible treatment for anorexia in the elderly, but proof of its efficacy is limited. Yeh et al. conducted a placebo-controlled trial among institutionalized elderly subjects. A total of 69 subjects were enrolled in that study; however, only 51 completed it. Of those, 61.9% were reported to have gained at least 4 pounds after 3 months, whereas only 21.7% of the placebo group gained weight (P ⫽ 0.013).1 Deep venous thrombosis (DVT) has been found to occur in almost one-third of all megestrol users, according to one small study of nursing home residents.2 In the present study, the incidence of deep venous thrombosis was determined in a much larger population of institutionalized elderly. METHODS A retrospective chart review was performed of the 816resident Bronx division of the Jewish Home, a large teaching nursing home in New York City. All of the patients prescribed megestrol between January 1998 and October 2001 were identified by computerized pharmacy records. All cases of DVT during the same time period were selected from the clinical database. The charts of the patients who were indicated as both having a DVT and being prescribed megestrol The Jewish Home and Hospital for the Aged, Bronx, New York (B.K., Y.S., E.P.C.); Brookdale Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, New York (B.K., E.P.C.); and Miami VA GRECC, Miami VA Medical Center; and the University of Miami School of Medicine, Miami, Florida (E.P.C.). Address correspondence to: E. Paul Cherniack, MD, Miami VA GRECC, Miami VA Medical Center, University of Miami School of Medicine, 1201 NW 16 St., Miami, FL 33162. E-mail: [email protected].
Copyright ©2003 American Medical Directors Association DOI: 10.1097/01.JAM.0000083384.84558.75 ORIGINAL STUDIES
Results: The incidence of deep venous thrombosis in 246 users was 4.9% Conclusion: There is a six-fold higher incidence of deep venous thrombosis among megestrol users in this population than in the general population of institutionalized elderly. (J Am Med Dir Assoc 2003; 4: 255–256) Keywords: megestrol, elderly, deep venous thrombosis
were reviewed by an investigator to verify that patients were on megestrol at the time of occurrence of DVT and to ascertain if other risk factors for development of DVT were present, including: immobility, cancer, previous DVT estrogen treatment, or recent fracture. The authors of this study have no relationship with the manufacturers of megestrol acetate. RESULTS Table 1 shows the baseline demographic characteristics of the patients. A total of 246 nursing home residents (average age, 86.9 years) were given megestrol over the 3-year period studied. All subjects were treated with doses of 400 mg/day. Within this group, only 10 were noted to have had a DVT during the study period. Of those 10 residents, only 8 were on megestrol at the time of occurrence of their DVT, or a 4.9% incidence. Megestrol users who sustained a DVT used the agent for an average of 183 days. DISCUSSION The incidence of DVT in the community is approximately 0.1%,3 and the risk in nursing home residents is believed to be eight times that of the general population.4 Therefore, the incidence of DVT noted in this study is six-fold larger than one would expect in the absence of other factors. Although at least one previous study, Bolen et al.2 had identified DVT as a frequent common side effect of megestrol, we did not find as large incidence of DVT in our population. The Bolen study was performed on a very small number of subjects with a relatively limited follow-up time, which might Kropsky et al. 255
Table 1.
Baseline Demographic Characteristics
Male %
White %
Black %
Hispanic %
No data available %
23.1
50.4
22.4
16.3
10.9
CONCLUSION This study shows an association between the use of megestrol acetate and DVT among nursing home residents. Further research is needed to clarify the nature of this association. REFERENCES
account for differences between that study and the present investigation. An increased incidence of DVT in the use of megestrol for cachexia has been reported in Acquired Immune Deficiency Syndrome (AIDS)5 and cancer patients.6 In an examination of the hemostatic effect of megestrol in patients with gynecologic neoplasms, Oberhoff et al. did not note any effect of megestrol on parameters of coagulation such as clotting times, fibrinogen, factor VII, and thrombin-antithrombin III complex.7 Nursing home residents commonly have a number of risk factors for DVT such as immobility, frequent falls, or neoplasms, which are in and of themselves risk factors for DVT, and so it is difficult to attribute the incidence of DVT to megestrol use alone. This survey did not control for other DVT risk factors.
256 Kropsky et al.
1. Yeh SS, Wu SY, Lee TP, et. al. Improvement in quality of life measures and stimulation of geriatric cachexia: Results of a double-blind, placebocontrolled study. J Am Ger Soc 2000;43:485– 492. 2. Bolen J, Andersen RE, Bennet RG. Deep venous thrombosis as a complication of megesterol acetate therapy among nursing home residents. J Am Med Dir Assoc 2000;1:248 –252. 3. Heit JA, Silverstein MD, Mohr DN, et. al. The epidemiology of venous thromboembolism in the community. Thromb Haemost 2001;86:452– 463. 4. Heit JA, Silverstein MD, Mohr DN, et. al. Risk factors for deep venous thrombosis and pulmonary embolism: A population-based case-control study. Arch Int Med 2000;160:809 – 815. 5. Koller E, Gibert C, Green L, et. al. Thrombotic events associated with megestrol acetate in patients with AIDS cachexia. Nutrition 1999;15: 294 –298. 6. Loprinzi CL, Kugler JW, Sloan JA, et. al. Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. J Clin Oncol 1999;17:3299 – 3306. 7. Oberhoff C, Hoffman O. Winkler UH, et. al. Hemostatic effects of high-dose megestrol acetate therapy in patients with advanced gynecological cancer. Gynecol Endocrinol 2001;15:341–348.
JAMDA – September/October 2003